Mark Simmons

What are lyophilised beads? Lyophilised beads are durable spheres of freeze-dried material formed from accurately measured dispense volumes of customisable formulation. These single-dose beads – like lyophilised cakes – retain long-term stability at ambient temperature and therefore do not need expensive cold chain shipping or refrigeration during storage. This significantly increases the accessibility of diagnostic testing for difficult-to-reach patients, facilitating

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The enhancements seen in diagnostic testing over the last 40 years have been nothing short of remarkable. In the UK alone the survival rate of cancer patients has doubled, and much of this is attributed to earlier and targeted treatment, facilitated by accurate, early diagnosis. But for enhancements in diagnostic performance to deliver a step change in global health and

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Our latest whitepaper outlines the principle benefits of using lyophilised reagent beads to stabilise in vitro diagnostic assays. The 24 Page document explains how the single dose nature of a bead delivers benefits in dosage consistency, speed of reconstitution and reduced risk of contamination and wastage, as well as a number of manufacturing efficiency benefits. The whitepaper is available to

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What are Lyophilized beads? Lyophilized beads are durable spheres of freeze-dried material formed from accurately measured volumes of customizable formulation. Like all lyophilized formats, these single-dose beads retain long term stability at ambient temperature and consequently do not need expensive cold chain shipping or refrigerated storage. However Lyophilized beads also help to improve assay accuracy as well as delivering a

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Lyophilization: eliminating the need for cold chain logistics Lyophilization, also known as freeze-drying, is a process being increasingly adopted by in vitro (IVD) assay developers looking to simplify assay handling and storage. With the challenges of sustainability and the escalating cost of cold chain logistics, lyophilization provides an efficient, effective alternative means of maintaining assay stability. In this article, weRead more

Whether you are lyophilizing or air drying your assay, your ultimate goal is to stabilise it for transport and storage at ambient temperature without loss of functional performance. Both processes involve the removal of water to achieve this and enable you to: eliminate the need for cold chain storage extend shelf life at ambient temperature enable single assay protocols. However,Read more

Increasing the efficiency of molecular diagnostic assay manufacturing There are many reasons you might consider partnering with a new molecular diagnostic contract manufacturer. You may need to ramp up production quickly to meet increasing demand, or you could be looking to reduce production costs. Perhaps you want to mitigate the risk of a single source of supply, or perhaps an issue

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Lyophilisation is becoming increasingly popular with IVD test manufacturers looking to simplify assay handling and processing. This article outlines the key considerations when developing a freeze-dried IVD test and discusses some of the strategies which can be used to ensure rapid, successful and cost-effective assay development. What is lyophilisation? Lyophilisation is the process of removing water from a product toRead more

Managing your manufacturing processes in-house may initially appear to be the most streamlined and snag-free route to market. After all, what could benefit your production cycle more than having everything under one roof, ready for immediate analysis, testing and shipping? In reality, overseeing every aspect of production in-house can place a strain on resources, create bottlenecks and delay commercialisation and

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How secure is your assay manufacturing? Manufacturing in vitro diagnostic (IVD) assays in-house, or outsourcing to a single contract manufacturer, should result in the seamless integration of technology transfer, pilot batch production, validation and verification, regulatory submission and subsequently efficient large-scale output. After all, if all those processes are managed in one place the surely there is tighter control? But

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